(S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide injection and preparation method of (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide injection

A technology for pyrrolidine acetamide and injections, which can be used in pharmaceutical formulations, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as poor product stability, increased impurities, and easy crystallization , to achieve the effect of simple and feasible preparation process, not easy to be oxidized, and less impurities in the product

Inactive Publication Date: 2017-05-24
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide injection mainly has problems such as poor product stability, easy oxidation, easy crystallization during storage, and easy increase of impurities during the sterilization process.

Method used

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  • (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide injection and preparation method of (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide injection
  • (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide injection and preparation method of (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide injection
  • (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide injection and preparation method of (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection prepared according to the following steps:

[0022] Element Dosage (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 100g Propylene Glycol 19g Lecithin 18g Vitamin C 3g Ethylenediaminetetraacetic acid 5g Sterile water for injection Add to 2000ml

[0023] Make 1000 pieces

[0024] Preparation process:

[0025] 1. Concentrated preparation: Add 1 / 3 of the prescription amount of sterile water for injection into the batching tank, add the prescription amount of raw and auxiliary materials, stir, dissolve, and obtain a concentrated liquid preparation;

[0026] 2. Dilute preparation: take the concentrated preparation, add sodium bicarbonate or hydrochloric acid to adjust the pH to 6.0-7.0, add activated carbon with a mass fraction of 0.1%-0.3%, absorb and decolorize, filter through a 0.45 μm filter membrane, and collect the filtrate. Add sterilized water for injection to the ...

Embodiment 2

[0060] A (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection prepared according to the following steps:

[0061] Element Dosage (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 100g Propylene Glycol 15g Lecithin 17g Vitamin C 2g Ethylenediaminetetraacetic acid 3g Sterile water for injection Add to 2000ml

[0062] Make 1000 pieces

[0063] Preparation process: prepared according to the preparation process of Example 1.

[0064] According to the test method of Example 1, the stability test investigation and the impact test of the sterilization process on the increase of impurities were carried out respectively. The stability test results showed that the sample quality was stable in 6 months, and the quality was stable in 18 months for a long time. Therefore, the validity period of this product is at least 18 months. months. The test results of the effect of sterilization process on the increase of impurities show that the prescri...

Embodiment 3

[0066] A (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection prepared according to the following steps:

[0067] Element Dosage (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 100g Propylene Glycol 18g Lecithin 20g Vitamin C 2g Ethylenediaminetetraacetic acid 3g Sterile water for injection Add to 2000ml

[0068] Make 1000 pieces

[0069] Preparation process: prepared according to the preparation process of Example 1.

[0070] According to the test method of Example 1, the stability test investigation and the impact test of the sterilization process on the increase of impurities were carried out respectively. The stability test results showed that the sample quality was stable in 6 months, and the quality was stable in 18 months for a long time. Therefore, the validity period of this product is at least 18 months. months. The test results of the effect of sterilization process on the increase of impurities show that the prescri...

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Abstract

The invention provides a (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide injection. The (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide injection is characterized by being prepared by taking (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide, propylene glycol, lecithin, vitamin c and ethylenediamine tetraacetic acid as raw and auxiliary materials through steps of concentrating, diluting, filling and sealing, sterilizing, checking and packaging, wherein the use amount of the raw and auxiliary materials is as follows in percentage by weight: 68 percent to 76 percent of the (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide, 10 percent to 18 percent of the propylene glycol, 10 percent to 17 percent of the lecithin, 1 percent to 3 percent of the vitamin c and 2 percent to 5 percent of the ethylenediamine tetraacetic acid. The (S)-4-hydroxyl-2oxo-1-pyrrolidineacetamide injection prepared by the invention has the advantages that a product is not crystallized and not easily oxidized in a storage process, the increasing amount of impurities in a sterilization process is only 0.03 percent and the stability is good; the validity period reaches 18 months or more, the product contains few impurities during the validity period and the content of the total impurities is lower than 0.27 percent; a preparation process is simple and feasible and is worthy of being popularized in the market.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide injection and a preparation method thereof. Background technique [0002] The chemical name of levo-oxiracetam is: S-(-)-4-hydroxy-2-oxopyrrolidine-N-acetamide. It is a white microcrystalline powder with a melting point of 135-136°C and an optical rotation of -36°( C=1.00in water), the solubility of levoxiracetam is obviously better than that of racemate. The chemical structural formula is shown in the following formula: [0003] [0004] The drug was launched in Italy in 1987, and the listed dosage forms are tablets, 800mg; capsules, 800mg; injection, 1g / 5ml. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredients used are racemates. Ye Lei et al mentioned in the patent publication No. CN 103735545 A that levoxiracetam has an obvious wake-promoting effect on coma ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4015A61K9/08A61K47/24A61K47/10A61K47/22A61K47/18A61P25/28A61P25/00
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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